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PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Vifor (International) Inc.
PACKAGE LEAFLET : INFORMATION FOR THE USER
FERRUM FOL 100 MG / 350 MICROGRAMS CHEWABLE TABLETS
Ferrum Fol 100 mg / 350 micrograms
Chewable Tablets
iron as iron(III)-hydroxide polymaltose complex / folic acid
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet
1.
What Ferrum Fol chewable tablets is and what it is used for
2.
What you need to know before you take Ferrum Fol chewable tablets
3.
How to take Ferrum Fol chewable tablets
4.
Possible side effects
5.
How to store Ferrum Fol chewable tablets
6.
Contents of the pack and other information
PIL-YT260/IE/E05
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PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Vifor (International) Inc.
1.
WHAT FERRUM FOL CHEWABLE TABLETS IS AND WHAT IT IS USED
FOR
It is used in women before and during pregnancy, and during breast-feeding to
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2.
treat iron deficiency
prevent iron and folic acid deficiency
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRUM FOL
CHEWABLE TABLETS
Do not take Ferrum Fol chewable tablets
if you are/have
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allergic to iron(III)-hydroxide polymaltose complex, folic acid or any of the other
ingredients of this medicine listed in section 6
an iron overload in the body
disturbed use of iron by the body
reduced number of red blood cells (anaemia), not caused by iron deficiency, such as due
to
increased red blood cell breakdown
vitamin B12 deficiency
Warnings and precautions
Talk to your doctor or pharmacist before taking Ferrum Fol chewable tablets if you have
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an infection or tumour
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a vitamin B12 deficiency
The folic acid contained in Ferrum Fol chewable tablets may mask deficiencies of
vitamin B12.
Dark discolouration of the faeces may occur during treatment with Ferrum Fol chewable
tablets; however, this is harmless.
Other medicines and Ferrum Fol chewable tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following medicines can affect or be affected by Ferrum Fol chewable tablets:
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injectable iron medicines
Additional injectable, iron medicines are not recommended.
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medicines to treat epilepsy, particularly phenytoin
Inform your doctor before taking Ferrum Fol chewable tablets.
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chloramphenicol: a medicine to treat bacterial infections
PIL-YT260/IE/E05
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PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Vifor (International) Inc.
Your doctor will carefully monitor you if you take both medicines.
Pregnancy and breast-feeding
Negative influence on the foetus or the woman during pregnancy or breast-feeding is unlikely
according to the available data.
However, as a precaution: If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Ferrum Fol chewable tablets has no or negligible influence on the ability to drive and use
machines.
3.
HOW TO TAKE FERRUM FOL CHEWABLE TABLETS
Always take this medicine exactly as your doctor or pharmacist have told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose
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Treatment of iron deficiency with reduced number of red blood cells
2 to 3 tablets once daily or divided into separate doses
After normalisation of the red blood pigment (haemoglobin) value, continue with 1
tablet once daily until, at least, the end of pregnancy. This will replenish the iron stores
and provide the increased amount of iron required during pregnancy.
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Treatment of iron deficiency with normal number of red blood cells, and prevention
of iron and folic acid deficiency
1 tablet once daily
Method of use
Take Ferrum Fol chewable tablets during or immediately after a meal.
The tablets can be chewed or swallowed whole.
Duration of use
This is decided by the doctor and depends upon the degree of iron deficiency.
If you take more Ferrum Fol chewable tablets than you should
Contact your doctor or pharmacist if this occurs.
If you forget to take Ferrum Fol chewable tablets
Just take the next dose at the usual time. Do not take a double dose to compensate the
forgotten dose.
If you stop taking Ferrum Fol chewable tablets
Do not discontinue sooner than recommended as this may reduce the success of therapy.
PIL-YT260/IE/E05
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PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
Vifor (International) Inc.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequency:
Very rare, affects less than 1 user in 10,000
• abdominal pain
• constipation
• diarrhoea
• nausea,vomiting,
• indigestion
• skin rash
• itching
Not known: frequency cannot be estimated from the available data
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headache
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bloody stool
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tooth discolouration
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increased appetite
If you get any any side effects talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet.
5. HOW TO STORE FERRUM FOL CHEWABLE TABLETS
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6.
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Store in the original blister in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the label and carton after
“Exp.:”. The expiry date refers to the last day of that month.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Ferrum Fol contains
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The active substances are:
iron as iron(III)-hydroxide polymaltose complex
folic acid
Each chewable tablet contains:
100 mg iron as iron(III)-hydroxide polymaltose complex
350 micrograms folic acid
PIL-YT260/IE/E05
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PIL-YT260/IE/E05
Ferrum Fol 100 mg / 350 micrograms
chewable tablets Ireland
•
Vifor (International) Inc.
The other ingredients are:
chocolate essence
cocoa
dextrates
microcrystalline cellulose
macrogol 6000
sodium cyclamate
talc
vanillin
What Ferrum Fol looks like and contents of the pack
Ferrum Fol chewable tablets are brown-white speckled, round and flat, with score line on one
side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
Packages contain 10, 30 (3 packs of 10) or 500 (50 packs of 10) chewable tablets packed in
aluminium strips.
Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Vifor France SA
7-13, Bd Paul Emile Victor
92200 Neuilly-sur-Seine
France
Tel: +33 (0) 1 41 06 58 90
Fax: +33 (0) 1 41 06 58 99
This leaflet was last revised in 06/2013.
PIL-YT260/IE/E05